Director, Medical Writer

Are you passionate aboutthe communication of clinical data in a regulatory context Do you have experienceinmedical writing

If so now is your chance to join Ascendis Pharma as our newMedical Writer.

Ascendis Pharmais a global biopharmaceutical company committed to making a meaningful difference in patients lives. Guided by our core values of Patients Science and Passion we are applying our innovativeTransCon technology platform to fulfill our mission of developing new therapies thatdemonstratebest-in-class potential to address unmet medical needs.

At our headquarters in Hellerup Denmark research facilities in Heidelberg Germany andadditionaloffices across Europe and the United States we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development ofTransCon-based products in other therapeutic areas and markets.

We are seekinga passionateMedical Writerto join our growingdedicated and teamis responsible forpreparing quality communications about our clinical data with a regulatory passion for and experience in medical writing and yourcollaborativeworking styleprovidethe opportunity to makeoutstandingcontributions toourprograms.

This is an exciting opportunity to work in a fast-paced environmentcollaboratingwith cross-functional global teams working together to achieve extraordinary results.

As our new MedicalWriteryou will be joining the Global Regulatory Communication team which has team membersbased in both Denmark and will be based inHellerup Denmark.

Your key responsibilities will be:

• Planning developing and/or providing oversight ofdiverseclinical regulatory documents including CSRs Investigator BrochuresNDA/BLA/MAA PIPs briefing packages responses to agency questions and other document types.

• RepresentingMedical Writing on cross-functional project teams and providing advice and guidance on regulatory document requirements and presentation of data.

• Leading or contributing to the development/optimization of processes systems templates and standards.

• Preparing or reviewing documents for public release including lay language summaries.

Qualifications and Skills:

You hold a relevant academic degree(preferablyMastersor higher level)have experience within the pharma industry and10years within Medical Writing.

Furthermoreyou have:

• Experience leading orhavinga major rolein submissionpreparation(NDA/BLA/MAA).

• Proven ability to work with and lead cross-functional global teams of contributors.

• Experience in authoringa variety ofclinicalandregulatory documents.

• Excellent verbal and written communication skills with the ability to effectively communicate with a variety of teams and individuals acrosstime zones.

• Ability to understandinterpretand communicate data from clinical trials.

• English atexceptionalprofessional level both written and spoken.

• An interest in developing and improving medical writing-related processes including digital/AIsolutions.

Key competencies:

To succeed in this roleyoumust bea strong teamplayerproactive in nature and witha can-do attitude. You like tooperatein an environment with opportunities to havehighimpact. You are comfortable working independently and can take decisions in complex situations.

Youpossessan entrepreneurial mindset and can thrive in an informal open environment where innovation and change are key.

Travel:canbe 5-10daysper year.

Office:Hellerup Denmark

Apply now.

We evaluate applications when received so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.

To ensure your application is reviewed pleasesubmitit through the specified platform - applications sent by email or other channels will not be evaluated.

For more detailsabout the position please

You can learn more about Ascendis by visitingour website

Applicationsmust besubmittedin English and will be treated confidentially.

A note to recruiters:

We do not allow external search party of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not this occurs your ownership of these candidates will not be acknowledged.

Required Experience:

Director